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510(k) K200728

Pitkar DeftFix System by S.H.Pitkar Orthotools Pvt. , Ltd. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2020
Date Received
March 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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